Ongoing Knowledge Developments Regarding Health Hazards of Metalworking Fluids

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1 Ongoing Knowledge Developments Regarding Health Hazards of Metalworking Fluids Franklin Mirer, PhD, CIH Hunter College Urban Public Health Program American Industrial Hygiene Conference and Exposition Philadelphia, PA June 4,

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3 TRW Automotive Mt. Vernon, Ohio UAW Local 1939 First Hypersensitivity Pneumonitis case November 2000 Diagnosis - January 2001 OSHA Inspection, no citations for MWF - March Restrictions 37 Still on Medical Leave for respiratory problems Hypersensitivity Pneumonitis 12 cases diagnosed 3

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5 Court to Workers (March 2004): Prior to issuing intent to set a standard, OSHA s decision to do nothing is not reviewable. 5

6 3 rd Circuit Court of Appeals (2004): 6

7 What Did They Know, and When Did They Know It? 7

8 Who are They? OSHA 3 rd Circuit Court of Appeals NIOSH ACGIH Lubricant Manufacturers Management Unions Occupational Health Community 8

9 What Does It Mean to Know? Government regulation or law (OSHA) Authoritative recommendation by governmental agency (NIOSH) Consensus standard (ANSI) Authoritative recommendation by professional group (ACGIH) Peer reviewed review papers Peer reviewed research report Meeting presentations Technical reports Community experience 9

10 What s to Know? Cancer studies of illness in people Cancer laboratory studies Respiratory effects Microbial composition Aerosols and measurement (informs exposure evaluation for people studies) Control technology and effectiveness 10

11 What is MWF exposure? 11

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13 STRAIGHT SOLUBLE SYNTHETIC OIL OIL FLUID Petroleum Oil (PNA's) Edible Oil Chlorinated Paraffin Sulfur Petroleum Sulfonates Biocides Nitrites(nitrosamines) Non-ionic surfactant Alkanolamines Borates Microorganisms Water MACHINING FLUID COMPOSITIONS 13

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15 MWF Timeline Scientific and Regulatory Timeline 1850 s Mule spinner s disease 1945 Milacron introduces modern soluble oil MWF 1962 ACGIH adopts 5.0 mg/m 3 oil mist TLV 1971 OSHA adopts ACGIH 5.0 mg/m 3 oil mist TLV as PEL 1976 IARC lists nitroso diethanolamine (measured in MWF) as Group 2B 1984 IARC lists some oils as Group Kennedy et al attribute Cross Shift PFT drop to MWF at 0.24 mg/m 3 (MFTP thoracic) 15

16 MWF Timeline Scientific and Regulatory Timeline (2) 1992 Eisen et al Mortality Study attributes excess cancer (exposure response) to MWF exposure 1993 UAW Petition for new standard, interim recommendation at 0.5 mg/m MVMA Conferences 1996 OSHA announces MWF Standards Advisory Committee 1997 NIOSH-UAW-Chrysler joint workshop on MWF-associated Hypersensitivity Pneumonitis 16

17 NIOSH Criteria Document (1998) 17

18 OSHA MWF Standards Advisory Committee (July 1999): 11-4 in favor of OSHA Standard based on UAW-NIOSH Recommended Limit Majority: 0.5 mg/m 3 MWF maintenance medical surveillance MRP-MPR Minority: voluntary programs MWF maintenance 18

19 MWF SAC: Stakeholder committee, not a scientific expert committee Systematic review of health effects was based almost entirely on NIOSH criteria document Other technical issues largely on NIOSH criteria document 19

20 MWF SAC (2): OSHA staff presented draft quantitative risk assessment data and draft economic data, but not in form to be included in the SAC report Little discussion and debate of cancer conclusions SAC Report relied on NIOSH criteria document for cancer conclusions 20

21 MWF SAC (3): OSHA denial of petition and brief relied on MWF SAC report 3 rd Circuit Court of Appeals relied on OSHA s statement of facts Is there new knowledge since to support reconsideration of MWF? 21

22 MWF Timeline Scientific and Regulatory Timeline (3) 1998, January NIOSH Criteria Document recommends 0.5 mg/m 3 limit 1999, July OSHA MWF SAC recommends 0.5 mg/m 3 limit 1999 MWF remains on OSHA s long term action list TRW HP outbreak 2001 Eisen mortality study update attributes increased cancer to MWF exposure 2001, October OSHA removes MWF standard from long term actions 2001, December OSHA publishes removal of MWF from regulatory agenda 22

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24 MWF Timeline Scientific and Regulatory Timeline (4) 2003, October 2 ACGIH conference regarding proposed oil mist TLV 2003, October 29 UAW and Steelworkers file suit to compel OSHA to set a MWF standard 2003 December OSHA formally denies 1993 petition rd Circuit upholds OSHA s refusal to set a standard for MWF 24

25 Record Closed 1999 What Happened Since 1999? 25

26 Metalworking Fluids and Cancer 24 Publications 26

27 NIOSH Criteria Document (1998): Substantial evidence exists for increased risk of cancer at several sites (larynx, rectum, pancreas, skin, scrotum and bladder) among workers exposed to MWF s before the mid-1970 s. Evidence is equivocal for cancer at several other sites, including stomach, esophagus, lung, prostate, brain, colon and hematopoietic system 27

28 Since NIOSH (1998): Eisen EA, Bardin J, Gore R, Woskie SR, Hallock MF, Monson RR, Exposureresponse models based on extended follow-up of a cohort mortality study in the automobile industry. Scand J Work Environ Health Aug;27(4):

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30 Eisen (2001): Cause obs exp SMR All All cancers * Stomach Liver * Pancreatic Lung * Leukemia * NMRD

31 Eisen (2001): Original and Update Cause All All * All cancers 1.05* * Stomach * Liver 1.42* * Pancreatic * Lung 1.08* * Leukemia 1.34* NMRD

32 Since NIOSH (1998): Eisen EA, Bardin J, Gore R, Woskie SR, Hallock MF, Monson RR, Exposureresponse models based on extended follow-up of a cohort mortality study in the automobile industry. Scand J Work Environ Health Aug;27(4): Sullivan P, Eisen E, Kreibel D, Woskie S, Wegman D., A nested case-control study of stomach cancer mortality among automobile machinists exposed to metalworking fluid. Ann. Epidemiol Oct 1;10(7):

33 Since NIOSH (1998): Kazerouni N, Thomas TL, Petralia SA, Hayes RB. Mortality among workers exposed to cutting oil mist: update of previous reports. Am J Ind Med Oct;38(4): Park RM. Mortality at an automotive engine foundry and machining complex. Journal of Occupational & Environmental Medicine. 43(5):483-93, 2001 May. Delzell E, Brown DA, Matthews R, Mortality among hourly motor vehicle manufacturing workers. J Occup Environ Med Aug;45(8):

34 Sullivan (2000): When data from three plants were combined, grinding with water-based synthetic or soluble MWF increased the risk of stomach cancer mortality. Those grinding with synthetic MWF with more than 1.3 mg/m(3)-years exposure during the 10 years just prior to death experienced a 4.4-fold risk of stomach cancer (95% CI ). Increased risk was also observed among those in the highest category of soluble grinding grading exposure (OR 1.9; 85% CI ). In plantspecific analysis, there was evidence of increased risk of stomach cancer associated with exposure to straight MWF and iron, as well as the water-based fluids 34

35 Kazerouni - NCI (2000): The SMRs for liver and biliary tract, and testicular cancers were significantly elevated. Among the subset of workers with heavy oil mist exposure, SMRs were significantly elevated for cancers of the lung and testis, and for Hodgkin's disease. The risk of death due to lung cancer was greatest among workers with heavy exposure to oil mist employed for 15 or more years. Mortality due to stomach cancer was in excess among workers with heavy exposure to oil mist who were employed for 5 or more years. There were significant excesses of deaths due to asthma and emphysema. 35

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40 Respiratory Effects of MWF 43 Publications 40

41 Respiratory Effects of Metalworking Fluids: SYMPTOMS COMPLAINTS: cough, sinus, shortness of breath CROSS SHIFT LUNG FUNCTION DROP (in otherwise healthy individuals) OCCUPATIONAL ASTHMA HYPERSENSITIVITY PNEUMONITIS 41

42 Respiratory Effects Issues: Effect level? No effect level? Is endotoxin, a product of gram negative bacteria, the main cause of observed irritation, asthma, cross shift PFT drop? Can we stop the above by aggressive biocide use? Can management avoid spending money on ventilation by stepping up MWF management? 42

43 Respiratory Effects Issues (2): Are mycobacteria, previously atypical in MWF, a cause of hypersensitivity pneumonitis? Necessary? Sufficient? Does aggressive biocide use encourage growth of mycobacteria? Can management avoid spending money on ventilation by stepping up MWF management? 43

44 Respiratory Effects Among Workers Exposed at Low Levels and to Straight Oils Kennedy, S.M., Chan-Yeung, M., Teschke, K. And Karlen, B. (1999) Change In Airway Responsiveness Among Apprentices Exposed To Metalworking Fluids. Am J Respir Crit Care Med 159,

45 Animal Model for MWF induced Hypersensitivity Pneumonitis: Thorne, P.S., Adamcakova-Dodd, A., Kelly, K.M., O'neill, M.E. And Duchaine, C. (2006) Metalworking Fluid With Mycobacteria And Endotoxin Induces Hypersensitivity Pneumonitis In Mice. Am J Respir Crit Care Med 173,

46 Major Outbreak of HP with strong evidence of no mycobacteria: Dawkins, P., Robertson, A., Robertson, W., Moore, V., Reynolds, J., Langman, G., Robinson, E., Harris-Roberts, J., Crook, B. and Burge, S. (2006) An outbreak of extrinsic alveolitis at a car engine plant. Occup Med (Lond) 56,

47 Skin Disorders 27 Publications 47

48 Liver Toxicity from Dermal Application of Typical MWF: Al-Humadi, N.H., Shvedova, A.A., Batteli, L., Diotte, N., Castranova, V. And Kommineni, C. (2000) Dermal And Systemic Toxicity After Application Of Semisynthetic Metal- Working Fluids In B6c3f1 Mice. J Toxicol Environ Health A 61,

49 Microbial Research 35 Publications 49

50 Microbial Measurements by Conventional Methods are Ineffective: Wallace Jr, R.J. Jr, Zhang, Y., Wilson, R.W., Mann, L. And Rossmoore, H. (2002) Presence Of A Single Genotype Of The Newly Described Species Mycobacterium Immunogenum In Industrial Metalworking Fluids Associated With Hypersensitivity Pneumonitis. Appl Environ Microbiol 68,

51 Biocides Promote Growth of Atypical Microorganisms: Watt, W.D. (2003) Observations On The Relationship Between Triazines And Mycobacteria In Metal Removal Fluids. Appl Occup Environ Hyg 18,

52 Feasible Engineering Controls for Machining Operations 52

53 Recirculating Mist Collectors Release Small Particles and Oil Vapor into the Work Environment: Boundy, M., Leith, D., Hands, D., Gressel, M. And Burroughs, G.E. (2000) Performance Of Industrial Mist Collectors Over Time. Appl Occup Environ Hyg 15,

54 Away from the operator interface, MWF particulate is largely 1 micron particles Dasch, J., D'arcy, J., Gundrum, A., Sutherland, J., Johnson, J. And Carlson, D. (2005) Characterization Of Fine Particles From Machining In Automotive Plants. J Occup Environ Hyg 2,

55 Enclosure and Exhaust Can Bring Existing Operations into Compliance: Sheehan, M. J., and D. Hands. (2007) "Metalworking Fluid Mist--Strategies to Reduce Exposure: a Comparison of New and Old Transmission Case Transfer Lines." J Occup Environ Hyg 4, no. 4:

56 Take Home Lessons: All interesting exposures are mixed exposures. Most single agent standards based on data from people are derived from mixed exposure scenarios OSHA s decision to withdraw was based and justified by the 1998 body of knowledge. New evidence on MWF cancer has emerged and reinforced previous studies 56

57 Take Home Lessons (2): It s a whole new microbial world New evidence on exposure composition and measurement informs past studies of health effects 57

58 Acknowledgements: Michael Silverstein Robert Park Dennis O Brien Richard Cardinal Randy Rabinowitz 58

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I ncreased risks of aerodigestive tract cancers have been

I ncreased risks of aerodigestive tract cancers have been 426 ORIGINAL ARTICLE Risk of upper aerodigestive tract cancers in a case-cohort study of autoworkers exposed to metalworking fluids A Zeka, E A Eisen, D Kriebel, R Gore, D H Wegman... See end of article